NIOSH Public Meeting

PPT Conformity AssessmentSeptember 17, 2013

Summary of Key Conformity Assessment Aand Examples of U.S. Programs Richard W. MetzlerSenior Scientist NPPTL, Office of the Director
“Demonstration that specified requirem

relating to a product, process, systemperson or body are fulfilled” ISO/IEC 17000:20

Conformity assessment Vocabulary and general principles

 Provide consumers with added confidenc Give the company a competitive edge Help regulators ensure that health, safety 

environmental conditions are met 

Conformity Assessment
Conformity Assessment in a 

Quality Infrastructure
Functional Approach to 

Conformity Assessment
 Develops policy and publishes standa

Promote mutual recognition and acceptan

national and regional conformity assessmsystems, and the appropriate use of InterStandards for testing, inspection, certificaassessment and related purposes

Published 28 conformity assessment stanParticipating countries: 71 – ANSI is US 

representative

Observing countries: 48

ISO Conformity Assessment 

Committee on Conformity Assessment (CA
 Main forms of conformity assessment

 Certification - ISO/IEC 17065 – 2012, Require

bodies certifying products, processes and s

 Inspection - ISO/IEC 17020 – 2012, Requirem

the operation of various types of bodies perinspection

 Testing - ISO/IEC 17025 – 2005, General requ

for the competence of testing and calibratiolaboratories

ISO Conformity Assessment
 Main forms of conformity assessment (

 Accreditation - ISO/IEC 17011- 2004, Genera

requirements for accreditation bodies accreconformity assessment bodies 

 Surveillance - ISO/IEC 17011, ISO/IEC 17065

ISO/IEC 17020

 Supplier’s Declaration of Conformity - ISO/I

Part 1: General requirementsPart 2: Supporting documentation

ISO Conformity Assessment
 Main forms of conformity assessment (

 Quality management systems - ISO/9001 – 2

Requirements for a quality management syste

demonstrate the ability to provide products thcustomer and applicable regulatory requirem

 Registration - ISO/IEC 17021 – 2011, Require

bodies providing audit and certification of management systems

ISO Conformity Assessment
 A uniform comprehensive program does not e

 Consensus standards do not typically contain 

requirements (ANSI, ASTM)

 OSHA basic health and safety requirements 

“incorporate by reference” U.S. consensus st

 Consequently, supplier's declaration of confo

no third-party verification or follow-up market surveillance and enforcement is the norm

U.S. PPT Conformity Assessment
 Current CA programs are product-directed an

designed primarily for products that protect wagainst serious (medium to high) hazards

 Consequently, both private and public sectors 

CA requirements in different ways to like haza

Examples: NIOSH (respirators) and NIJ (bomb suits) NFPA (fire and emergency services products) 

U.S. PPT Conformity Assessment
Certification Activities

 Engineering Evaluation Respirator Testing QA Plan Evaluation 

Post Market Activities

 Manufacturing Site Audits Respirator Product Audits  Respirator Evaluations

42CFR84 NIOSH Respirator 

Conformity Assessment Activities
 NIJ Standard – 0117.00 Public Safety Bomb S

Standard, March 2012

 Voluntary performance standard providing for o

protection

 Defines both performance requirements and th

used to test performance 

 “Incorporates by references” national and intern

standards (NFPA, MIL, ANSI, ASTM, EDA, IEC

NIJ/DOJ/Office of Justice Program

Public Safety Bomb Suit
 NIJ CR – 0117.00 Public Safety Bomb Suit Cer

Program Requirements, March 2012 

 Certification (ISO/IEC Guide 65) with additional 

requirements (e.g. surveillance frequencies, safety 

product recalls, independent third parties for testing inspections) 

 Testing (ISO/IEC 17025)  Inspections (ISO/IEC 17020) Quality management system (ISO 9001) Registration (ISO/IEC 17021)

NIJ/DOJ/Office of Justice Program

Public Safety Bomb Suit
 13 PPT and PPE product standards apply Certifica

(Chapter 4) requirements

 Third-party certification (ISO/IEC 17065) Notified body accreditation (ISO/IEC 17011) Inspection and testing (ISO/IEC 17025) Annual recertification Manufacturer's quality assurance program (ISO-900 Registration (ISO/IEC 17021) Investigation of hazards (ISO Guide 27) Manufacturer's investigation of complaints and retu Manufacturer safety alert and product recall system

NFPA - Fire and Emergency Service

Conformity Assessment 
 Existing PPT CA programs in the U.S. represent 

diversity of approaches

 Current requirements for pre-market CA and post 

surveillance and enforcement varies across prodintended for like levels of hazard 

 Merger of private and public sector CA programs 

a national framework to deliver a uniform compreprogram providing confidence in a standard level protection for workers 

U.S. PPT Conformity Assessment
Quality Partnerships Enhance Wor

Safety & Health

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Disclaimer:The findings and conclusions in this presentation have not been formdisseminated by the National Institute for Occupational Safety and Hshould not be construed to represent any agency determination or po

Thank you!